syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
Check against the official notice below — it lists the full affected range.
Siemens Medical Solutions has issued a recall for upgraded syngo.via RT Image Suite software (version VB60) running on SOMATOM go.Up CT scanning equipment. When the software was upgraded, it made an automatic change to laser configuration settings for "markerless workflow" that may cause incorrect laser offset coordinates to be displayed during the Patient Marking step of the scanning process. The affected equipment has been distributed worldwide, including across multiple U.S. states and numerous countries.
One unit in the United States was involved in this recall, identified by partial UDI 04056869051314 and serial number 112261. The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.
Reason for recall: Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step. Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, IL, IN, KY, MD, MO, ND, NH, NY, OH, OR, PA, SD, TX, VA and the countries of Argentina, Austria, Bahrain, Belgium, Brazil, Czechia, Denmark, France, Germany, Hungary, India, Italy, Japan, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Switzerland, United Kingdom. Quantity: 1 (US) Lot/code info: Partial UDI: 04056869051314, Serial Number 112261
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.